Human hallucinogen research: guidelines for safety
Open accessAbstract
There has recently been a renewal of human research with classical hallucinogens (psychedelics). This paper first briefly discusses the unique history of human hallucinogen research, and then reviews the risks of hallucinogen administration and safeguards for minimizing these risks. Although hallucinogens are relatively safe physiologically and are not considered drugs of dependence, their administration involves unique psychological risks. The most likely risk is overwhelming distress during drug action ('bad trip'), which could lead to potentially dangerous behaviour such as leaving the study site. Less common are prolonged psychoses triggered by hallucinogens. Safeguards against these risks include the exclusion of volunteers with personal or family history of psychotic disorders or other severe psychiatric disorders, establishing trust and rapport between session monitors and volunteer before the session, careful volunteer preparation, a safe physical session environment and interpersonal support from at least two study monitors during the session. Investigators should probe for the relatively rare hallucinogen persisting perception disorder in follow-up contact. Persisting adverse reactions are rare when research is conducted along these guidelines. Incautious research may jeopardize participant safety and future research. However, carefully conducted research may inform the treatment of psychiatric disorders, and may lead to advances in basic science.
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Therapeutic outcomes of psychedelic-assisted therapies appear strongly influenced by psychological "set," environmental "setting," and structured post-session integration.
“Therapeutic outcomes appear strongly influenced by psychological “set” (mindset, expectations, preparation), environmental “setting,” and structured post-session integration (96, 99, 107, 108), highlighting the central role of context, support, and integration in optimizing benefit.”
From The therapeutic role of self-transcendence in moral injury recovery: theory, mechanisms, and clinical implications (2026) · cites this paper as [96]
The Preparation of volunteers, Physical environment, and Post-session procedures sections recommend preparation, supportive surroundings, and follow-up discussion; the latter says participants seem to benefit from time to reflect. But Early clinical research calls therapeutic findings under supportive conditions largely anecdotal or inconclusive. The paper therefore supports the importance of these practices, not the stronger claim that all three strongly influence therapeutic outcomes. (LLM, conf=0.84)
Experimental — accuracy not yet measuredSerotonergic psychedelics are not associated with addiction.
“are not associated with addiction [9, 11, 12]”
From Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial (2024) · cites this paper as [9]
The “Abuse and dependence” section says hallucinogens are not typically considered drugs of dependence and pose little risk of leaving research participants dependent. It also says they can be abused, so the unqualified statement that they are not associated with addiction overstates the paper’s more cautious conclusion. No page number is available in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredIndividuals with a lifetime history of psychotic or bipolar disorders or with a family history of these conditions in first- or second-degree relatives are at risk of inducing a psychotic or manic episode.
“individuals with a lifetime history of psychotic or bipolar disorders or with a family history of these conditions in first- or second-degree relatives are currently excluded from participation to prevent the risk of inducing a psychotic or a manic episode in those with these conditions or with a potential genetic vulnerability [9].”
From Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial (2024) · cites this paper as [9]
The Selection of volunteers section says the researchers exclude people with a current or past psychotic or bipolar I or II disorder, as well as those with a first- or second-degree relative with these disorders, to improve safety. It specifically links screening to reducing the risk of a prolonged psychotic reaction, but does not explicitly identify an induced manic episode as a risk. The Prolonged psychosis section also cautions that causation is uncertain. (LLM, conf=0.84)
Experimental — accuracy not yet measuredBoth antipsychotics and benzodiazepines can reduce the acute effects of psychedelics.
“In addition, both antipsychotics and benzodiazepines can reduce the acute effects of psychedelics (Johnson et al., 2008).”
From Naturalistic psychedelic therapy: The role of relaxation and subjective drug effects in antidepressant response (2024) · cites this paper as Johnson et al., 2008
In “Conduct of hallucinogen administration sessions” (page not supplied), the paper recommends benzodiazepines for acute psychological distress and says antipsychotics may reduce psychotic behavior through sedation. It does not establish that both drug classes reduce psychedelic effects generally; it also reports that haloperidol pretreatment can exacerbate psilocybin’s psychosis-like effects. (LLM, conf=0.87)
Experimental — accuracy not yet measuredWhen implemented with appropriate methodological and ethical safeguards, these approaches are associated with improvements in psychological well-being, adaptive reappraisal, and meaning reconstruction.
“When implemented with appropriate methodological and ethical safeguards (73, 95, 96), these approaches are associated with improvements in psychological well-being, adaptive reappraisal, and meaning reconstruction (36, 57, 65, 97–99).”
From The therapeutic role of self-transcendence in moral injury recovery: theory, mechanisms, and clinical implications (2026) · cites this paper as [96]
Serotonergic psychedelics present very low long-term toxicity.
“These compounds present very low long-term toxicity [9, 10]”
The psychedelic experience comes with an increased sensitivity to internal and external stimuli.
“The psychedelic experience comes with an increased sensitivity to internal and external stimuli.”
The general context of psychedelic administration fundamentally shapes drug response, safety, and potentially therapeutic efficacy.
“It follows that the general context of psychedelic administration fundamentally shapes drug response and hence safety, as well as potentially therapeutic efficacy [9, 88].”
Psychedelics generally intensify emotional experience and may give rise to anxiety, dysphoria, fear, panic, or paranoia.
“Psychedelics generally intensify emotional experience and may give rise to anxiety, dysphoria, fear, panic, or paranoia [9].”
The design of the ayahuasca-assisted intervention is based on the contemporary structure of PAP, which typically involves a three-stage framework encompassing preparation, facilitation, and integration.
“This design is based on the contemporary structure of PAP, which typically involves a three-stage framework encompassing preparation, facilitation, and integration (104).”
From Ayahuasca-assisted meaning reconstruction therapy for grief: a non-randomized clinical trial protocol (2025) · cites this paper as [104]
Risks associated with psychedelic consumption include transient anxiety, panic and, very rarely, prolonged psychosis.
“These risks include transient anxiety, panic and, very rarely, prolonged psychosis [42].”
From The psychological processes of classic psychedelics in the treatment of depression: a systematic review protocol (2022) · cites this paper as [42]
Providing empathetic support during and after a psychedelic experience represents a fundamental ethical requirement.
“Due to the potential of psychedelics to elicit profound psychological and emotional responses, providing empathetic support during and after a psychedelic experience represents a fundamental ethical requirement (84, 89).”
From Potential therapeutic effects of an ayahuasca-inspired N,N-DMT and harmine formulation: a controlled trial in healthy subjects (2024) · cites this paper as [89]
Niacin was used as an active placebo that produces an acute physiological response (flushing) thought to aid in blinding.
“Niacin was used as an active placebo that produces an acute physiological response (flushing) thought to aid in blinding.8,22”
From Single-Dose Psilocybin Treatment for Major Depressive Disorder: A Randomized Clinical Trial (2023) · cites this paper as [22]
The Preparation of volunteers section discusses blinding and an active placebo, but identifies that placebo as methylphenidate. Searches for niacin and flushing found no passage in our copy addressing niacin’s use, its physiological response, or whether it aided blinding. (LLM, conf=0.72)
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“A more detailed description of the study room and procedures followed on session days is provided elsewhere (Griffiths et al., 2006; Johnson et al., 2008).”
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“For each session a physician was on call, and rescue medications were available in case of adverse cardiovascular or psychological events (Johnson et al., 2008).”
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“Guidelines have been described to minimize adverse reactions in controlled settings (Johnson et al., 2008), and incidence of lasting symptoms (including psychosis) related to administration of classic hallucinogens in controlled settings is quite low (Griffiths et al., 2006, 2011; Strassman, 1984;…”
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- Authors
- Johnson, M., Richards, W., & Griffiths, R.
- Affiliations
- Johns Hopkins University (US)
- Johns Hopkins Bayview Medical Center (US)
- Corresponding author
- Griffiths, RR
- Venue
- Journal of Psychopharmacology
- Publisher
- SAGE Publications
- Published
- 2008-05-30
- Volume
- 22
- Issue
- 6
- Pages
- 603-620
- ISSN
- 0269-8811 (ISSN-L)
- 1461-7285
- PMC
- PMC3056407
- OpenAlex
- W2113099805
- Semantic Scholar
- 554f798f25a69d215bea816211ae014c5319edac
- Cited by
- 1,203
- References
- 154
- Citations by year
- 2026: 128 · 2025: 164 · 2024: 167 · 2023: 152 · 2022: 170 · 2021: 97 · 2020: 84 · 2019: 40 · 2018: 42 · 2017: 37 · 2016: 36 · 2015: 21 · 2014: 18 · 2013: 12 · 2012: 12
- FWCI
- 1.32
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Psychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Funders
- National Institute on Drug Abuse (R01DA003889, R01DA03889)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Psychedelics and Drug Studies
- Health Sciences › Medicine › Psychiatry and Mental health › Schizophrenia research and treatment
- Life Sciences › Neuroscience › Cognitive Neuroscience › Hallucinations in medical conditions
- Keywords
- hallucinogens, psychedelics, bad trips, psychological distress, psychosis, hallucinogen persisting perception disorder, volunteer screening, adverse drug reactions
- MeSH terms
- Clinical Trials as Topic, Environment, Hallucinogens, Humans, Human Experimentation, Perception, Psychotic Disorders, Research, Safety, Practice Guidelines as Topic, Substance-Related Disorders
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